Arrest of Proximal Caries Using Orthodontic Bands and Glass Ionomer Cement as a Preventative Intervention: A Split Mouth Study

This study is designed to determine the efficacy of orthodontic bands and glass ionomer cement in arresting and remineralizing incipient carious lesions as compared to monitoring for changes.

This is a single blinded, split mouth randomized control trial, with the patient being their own control. A split mouth study is considered the gold standard because both experimental and control groups are exposed to the same environmet and conditions within the mouth. This study design eliminates confounding variables that may occur that could significantly alter the interpretation of end results (e.g. oral hygiene effectiveness between two patients).

Participants will be screened at their routine periodic dental examination, where they will receive a dental exam, prophylaxis (cleaning), radiographs and fluoride varnish application in accordance with the guidelines from the American Academy of Pediatric Dentistry. Radiographs will be examined by an evaluator to determine if participants meet the inclusion criteria. Each participant requires at least one pair of permanent posterior teeth with interproximal caries lesions in enamel or in proximity of the dentinal enamel junction (E1, E2, early D1). An ideal pair consists of the same tooth type on the left and right side of the mouth (i.e. tooth #5 and #12, maxillary right permanent first premolar and maxillary left permanent first premolar). Another acceptable type of pair is same tooth type (i.e. tooth #5 and #21, maxillary right permanent first premolar and mandibular left permanent first premolar) or two adjacent teeth (i.e tooth #19 and 18 mandibular left first and second molar). Additionally, patients may also be screened when coming in for other dental treatment as well.

Each participant will have his or her qualifying lesions randomized equally into two groups, one that will receive the band, and one that will not. Envelopes will contain the treatment conditions: Left/Upper/Distal or Right/Lower/Mesial, to indicate that the lesion on either the left/upper/distal or right/lower/mesial side of the mouth will get banded. They will be randomly organized and then ordered in the box.

After randomization has occurred, each participant will have a blank orthodontic band (Denovo) fitted on the treatment lesion and cemented with glass ionomer cement (Fuji). Additionally, oral hygiene instructions will be reinforced. Participants will be instructed to return for their routine periodic dental exam in 6 months. Because the intervention is obvious, blinding the patient or the operator is not possible. At the 6 month visit, the band will be removed with a band remover prior to their dental exam and cleaning. Routine radiographs (according to the AAPD's radiographic guidelines) will be taken after the band has been removed. 20,21,22